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NCT07086326PHASE2NOT_YET_RECRUITING

A Phase II Randomized Trial of Neoadjuvant Ivonescimab or Penpulimab Plus Chemotherapy in Resectable NSCLC

A Prospective, Randomized, Open-label, Controlled Phase Ⅱ Clinical Trial of Ivonescimab Combined With Chemotherapy Versus Penpulimab Combined With Chemotherapy for Neoadjuvant Treatment of Non-small Cell Lung Cancer (NSCLC)

Sponsor: Yang Fan, MD

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type
INTERVENTIONAL
Conditions
NSCLC, Neoadjuvant Therapy, Immunotherapy, AK112, Bispecific Antibody
Interventions
Ivonescimab+Chemo, Penpulimab+Chemo
Enrollment
164 participants
Primary completion
Dec 2026
Study completion
Dec 2027
First posted
Jul 2025
Last updated
Jul 2025

Primary Endpoints (CT.gov)

Pathologic Complete Response (pCR) Rate

Time frame: Within 1 month after surgery

Secondary Endpoints

Major Pathologic Response (MPR) Rate

Event-Free Survival (EFS)

Eligibility Criteria

Inclusion Criteria: 1. Voluntarily sign the written Informed Consent Form (ICF) and consent to receive curative surgical treatment. 2. Participants must be aged ≥ 18 years, regardless of gender. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status Score is 0-1. 4. Histologically confirmed resectable Stage IIA-IIIB (N2) non-small cell lung cancer (NSCLC) according to the 9th edition of the TNM staging system for lung cancer by the Union for International Cancer Control (UICC) and the American Joint Committee on Cancer (AJCC). 5. Prior to study enrollment, subjects must be evaluated by an attending thoracic surgeon responsible for the surgery to verify eligibility for R0 resection with curative intent. 6. NSCLC appears solid or subsolid (not purely ground-glass opacity \[GGO\]) on CT scan. For subsolid lesions, tumor size (i.e., clinical T stage) should be based solely on the solid component without measuring the GGO portion. 7. Normal pulmonary function test results. 8. At l

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov